Working Together to Accelerate Regulatory Submissions
“How can we submit sooner?” It’s long been the most common question a regulatory submissions team hears. Executive leaders have ambitious goals in mind for…
The September issue of RF Quarterly, a publication of the Regulatory Affairs Professionals Society (RAPS), features two articles authored by regulatory experts at Integrated Project Management Company, Inc. (IPM).
The editors of RF Quarterly invited proposals for contributions to the issue, which has a leadership theme. IPM Principal Consultant Susan Carino suggested two topics, and both were selected. Carino is chair of the San Francisco Bay Area RAPS Chapter and was recently named a RAPS Fellow, thanks to her contributions to her organization, RAPS, and the regulatory profession. A consultant with IPM since 2006, she provides regulatory expertise and program and project leadership to life sciences companies.
Carino enlisted several other regulatory leaders, including IPM colleague Rani Maloney, to co-author the content. Maloney, a senior consultant with 20 years’ experience in regulatory compliance and clinical quality, has a history of leading successful global, cross-functional teams.
The articles focus on leadership in regulatory affairs, tackling the topic in different ways.
- The first, “The Leadership Journey—Insights to Guide Life Sciences Regulatory Leaders,” compiles advice and experiences from 10 RAPS members. It covers a range of topics including challenges they have overcome, managing cross-functional teams, having tough conversations, and advancing in their careers. In it, Carino challenges readers to adjust their mindset to be more strategic, rather than concentrating on the facts and figures that scientists are used to. And Maloney urges leaders not to avoid conflict, but to embrace it, as it can be healthy and productive if managed correctly.
- The second, “Essential Regulatory Leadership Skills,” discusses the essential capabilities for regulatory professionals—collaboration, communication, conflict management, negotiation, talent management, and relationship management—and how each builds leadership competency. Besides Carino and Maloney, authors included four leaders with broad pharmaceutical and biopharma regulatory experience.
RAPS members can view RF Quarterly on the association’s website.
— Published October 12, 2023